Accelerate Diagnostics Achieves CE-IVD Milestone for ID/AST System and ID/AST Blood Culture Assay

Accelerate Diagnostics, Inc., announced its declaration of conformity to the European In Vitro Diagnostic Directive 98/79 EC and CE Mark of the Accelerate ID/AST System and ID/AST Blood Culture Assay for in vitro diagnostic use. The Accelerate ID/AST System is a diagnostic platform providing rapid identification and antimicrobial susceptibility testing of serious infections.

In addition, the company initiated enrollment at 8 clinical trial sites for its preclinical study. Upon successful completion the FDA registration trial will begin. Given the aforementioned progress, the company maintains its expectation that it will launch an FDA cleared product in the United States in the first half of 2016.